Matthew Greenhawt, MD

Credit: childrenscolorado.org

Twelve months of epicutaneous immunotherapy is effective in desensitizing children aged 1 - 3 to peanut products and increasing the original dose that triggers reactions in those with allergy, according to new findings.¹

These recent findings are a part of the expanding body of research suggesting that consuming peanuts during infancy may significantly reduce risk of a child having an allergy to the product. The research team in these new findings acknowledge that as a result, children’s developing immune systems may be substantially amenable to peanut desensitization.²

The research was authored by Matthew Greenhawt, MD, from the Department of Pediatrics’s Section of Allergy and Immunology at Children’s Hospital Colorado, University of Colorado School of Medicine.

Evidence of safety and efficacy in children with peanut allergy aged 4 - 11 years using a patch-based non-oral immunotherapy opened the doors to this new study.³

“On the basis of these findings, we conducted the phase 3 Epicutaneous Immunotherapy in Toddlers with Peanut Allergy (EPITOPE) trial to assess the efficacy and safety of epicutaneous immunotherapy with a peanut patch containing 250 μg of peanut protein (Viaskin Peanut, DBV Technologies) in children 1 to 3 years of age with peanut allergy,” Greenhawt and colleagues wrote.

Background and Findings

The investigators conducted a double-blind, randomized, placebo-controlled phase 3 study, during which they recruited children aged 1 - 3 years with a confirmed peanut allergy, determined by a double-blind, placebo-controlled food challenge.

Study articipants with an eliciting dose of 300 mg or less of peanut protein were randomly assigned by the research team into a 2:1 ratio to either be given a peanut patch for epicutaneous immunotherapy (intervention arm) or placebo each day for 12 months.

The trial was performed at 51 centers in 8 countries, including the United States, Australia, Canada, and other countries in Europe. The research team determined the appropriate dose for the young children in the study through a previously established substudy with peanut-protein patches at a 100 μg or 250 μg dose.⁴

Regarding the peanut patch intervention itself, it was known as Viaskin Peanut 250 μg and worked as an epicutaneous system made up of unmodified lyophilized peanut protein and an occlusive chamber.

The initial patch was given to the participants with medical supervision over a period of 3 hours, though they were then told by the research team to adjust the daily application duration at home during the preceding 4 weeks on a specific schedule.

The investigators’ primary outcome measure was decided to be a treatment response assessed by the eliciting dose of peanut protein following 12 months. Safety was then evaluated by monitoring adverse events during the use of the peanut patch or placebo.

Overall, out of the 362 randomized participants, 84.8% ended up completing the trial in full. The investigators’ primary endpoint was achieved by 67.0% of the children in the intervention arm compared to 33.5% of those in the placebo arm.

This resulted in a risk difference of 33.4 percentage points (95% confidence interval, 22.4 - 44.5; P<0.001). The team added that adverse events were shown to have occurred in 100% of those in the intervention arm and 99.2% in the placebo arm, with serious adverse events occurring in 8.6% and 2.5%, respectively.

Additionally, the investigators noted that anaphylaxis was seen in 7.8% and 3.4% of the participants, respectively. Treatment-related serious adverse events were observed in 0.4% of those in the intervention arm and none in the placebo arm, while treatment-related anaphylaxis was seen in 1.6% and none, respectively.

“Consistent with previous studies involving the use of the peanut patch, adverse events that occurred during the EPITOPE trial were reported in most patients but were primarily mild-to-moderate local skin reactions that decreased in frequency through the duration of the trial,” the research team wrote.

References

1. ^{Greenhawt M, Sindher SB, Wang J, O’Sullivan M, du Toit G, Kim EH, Albright D, Anvari S, Arends N, Arkwright PD, Bégin P, Blumchen K, et al. Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy. N Engl J Med. 2022 Apr 14;386(15):1414-1426. doi: 10.1056/NEJMoa2212895. PMID: 35273584.}
2. ^{Jones SM, Kim EH, Nadeau KC, et al. Efficacy and safety of oral immunotherapy in children aged 1–3 years with peanut allergy (the Immune Tolerance Network IMPACT trial): a randomised placebo-controlled study. Lancet 2022;399:359-371.}
3. ^{Pongracic JA, Gagnon R, Sussman G, et al. Safety of epicutaneous immunotherapy in peanut-allergic children: REALISE randomized clinical trial results. J Allergy Clin Immunol Pract 2022;10(7):1864-1873.e10.}
4. ^{Fleischer DM, Brown-Whitehorn T, Jones SM, et al. Epicutaneous immunotherapy (EPIT) for peanut allergy in young children: the EPITOPE clinical trial. J Allergy Clin Immunol 2019;143:Suppl:AB247-AB247.}